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Novartis's Phase III Asthma Study in Children Meets Endpoint

Posted on: Monday, 6 October 2008, 09:00 CDT

Novartis has announced positive results from a Phase III clinical study, which showed that Xolair, a treatment for allergic asthma in adolescents and adults, significantly reduced asthma attacks in children aged six to 11 years with uncontrolled moderate-to-severe persistent allergic asthma.

The study showed that after 24 weeks, children treated with Xolair suffered 31% fewer clinically significant exacerbations than those receiving placebo or dummy drug (p=0.007). The study therefore met its primary endpoint.

Over the entire one-year study, children treated with Xolair suffered 54.2% fewer exacerbations than those on placebo (p<0.001). Xolair was generally safe and well-tolerated in the clinical trial with no differences in adverse events compared with placebo, said Novartis.

The double-blind, placebo-controlled study assessed the efficacy and safety of Xolair in children aged six to 11 years (n=628) with moderate-to-severe persistent allergic (IgE-mediated) asthma. The study comprised a 24-week fixed-dose steroid phase, followed by a 28-week phase in which steroid dose could be reduced and a 16-week safety follow-up period.

Xolair is manufactured by Novartis Pharma. In the US, it is co-promoted by Novartis Pharmaceuticals and Genentech.

Trevor Mundel, head of global development functions at Novartis Pharma, said: "Xolair continues to improve the lives of asthma patients across the world, and Novartis is excited about the future opportunity to extend the use of this breakthrough treatment to help younger patients and their families."

Source: Datamonitor

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